CompletedPhase 2

KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia

China24 participantsStarted 2022-07-07

Plain-language summary

This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of multiple subcutaneous doses of KN057 in subjects with hemophilia A or B, with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). 24 adult participants 18 to 70 years of age with moderately severe to severe hemophilia A or hemophilia B (defined as FVIII or FIX activity ≤2%, respectively) with or without inhibitors (including 18 HA/HB patients without inhibitors and 6 HA/HB patients with inhibitors) are expected to be enrolled in this study during which they will receive prophylaxis treatment (defined as treatment by SC injection once weekly of KN057).

Who can participate

Age range

18 Years – 70 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male, 18-70 years old (including threshold), weight≥40kg;
. Moderately severe to severe hemophilia A or B (Factor VIII or Factor IX activity ≤2%)
. Participants who are enrolled into the Non-Inhibitor Cohort must meet the following criteria:
. Participants who are enrolled into the Inhibitor Cohort must meet the following criteria:
. Be willing to undergo a washout period of the original treatment regimen before the administration of KN057: at least 48 hours for recombinant activated coagulation factor Ⅶ (rFⅦa); at least 72 hours for FⅧ and prothrombin complex (PCC); at least 96 hours for FⅨ; For other drugs or investigational products with a long half-life, such as Emicizumab, at least five half-lives should have passed prior to dosing.
. Be willing to comply with the relevant management regulations of the clinical trial unit, and follow study procedures.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency and severity of treatment emergent adverse events(TEAEs)

Timeframe: Day 1 up to Day 85

Withdrawals due to TEAEs

Timeframe: Day 1 up to Day 85

Number of Participants With Abnormal Laboratory Findings-Hematology

Timeframe: Day 1 up to Day 85

Number of Participants With Abnormal Laboratory Findings-Urinalysis

Timeframe: Day 1 up to Day 85

Number of Participants With Abnormal Laboratory Findings-Blood biochemistry

Timeframe: Day 1 up to Day 85

Number of Participants With Abnormal Laboratory Findings-Coagulation tests

Timeframe: Day 1 up to Day 85

Number of Participants With Clinically Significant Changes in Vital Signs Data

Timeframe: Day 1 up to Day 85

Trial details

NCT IDNCT05421429

SponsorSuzhou Alphamab Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-17

View on ClinicalTrials.gov More Hemophilia trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male, 18-70 years old (including threshold), weight≥40kg;
. Moderately severe to severe hemophilia A or B (Factor VIII or Factor IX activity ≤2%)
. Participants who are enrolled into the Non-Inhibitor Cohort must meet the following criteria:
. Participants who are enrolled into the Inhibitor Cohort must meet the following criteria:
. Be willing to undergo a washout period of the original treatment regimen before the administration of KN057: at least 48 hours for recombinant activated coagulation factor Ⅶ (rFⅦa); at least 72 hours for FⅧ and prothrombin complex (PCC); at least 96 hours for FⅨ; For other drugs or investigational products with a long half-life, such as Emicizumab, at least five half-lives should have passed prior to dosing.
. Be willing to comply with the relevant management regulations of the clinical trial unit, and follow study procedures.

What they're measuring

Frequency and severity of treatment emergent adverse events(TEAEs)

Timeframe: Day 1 up to Day 85

Withdrawals due to TEAEs

Timeframe: Day 1 up to Day 85

Number of Participants With Abnormal Laboratory Findings-Hematology

Timeframe: Day 1 up to Day 85

Number of Participants With Abnormal Laboratory Findings-Urinalysis

Timeframe: Day 1 up to Day 85

Number of Participants With Abnormal Laboratory Findings-Blood biochemistry

Timeframe: Day 1 up to Day 85

Number of Participants With Abnormal Laboratory Findings-Coagulation tests

Timeframe: Day 1 up to Day 85

Number of Participants With Clinically Significant Changes in Vital Signs Data

Timeframe: Day 1 up to Day 85

KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

KN057 Multiple Dose Study in Moderately Severe to Severe Hemophilia

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria